HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
Device Facts
| Record ID | P810031 |
|---|---|
| Device Name | HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product Code | LZP · Ophthalmic |
| Decision Date | Jan 14, 1983 |
| Decision | APPR |
| Regulation | 21 CFR 886.4275 |
| Device Class | Class 3 |
Regulatory Classification
Identification
An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
